MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the reported complaint and the associated manufacturer report numbers are 1226348-2018-00801 & 3008264254-2018-00539.

Event Description

As reported by a healthcare professional, during a stent-assisted coil embolization of an intracranial aneurysm, after the physician placed the unspecified guide catheter and prowler select plus 150/5cm ((b)(4)/17541950) microcatheter in the correct position, he inserted the 4.5mm x 22mm enterprise (enc452212/10827625) stent vascular reconstruction device but found that it was difficult to push.The microcatheter was removed from the patient and the physician discovered a fold near the catheter tip.The microcatheter was replaced and the procedure was completed successfully without further incident.No patient complications occurred as a result of the event.The surgery was not delayed due to the event.The products were new and stored and handled according to the labeling instructions.The products were packaged securely as expected.No apparent damage was noted to the catheter packaging or shipping container.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.The products will be returned for evaluation.No further information could be obtained.

Manufacturer Narrative

Product complaint # (b)(4).As reported by a healthcare professional, during a stent-assisted coil embolization of an intracranial aneurysm, after the physician placed the unspecified guide catheter and prowler select plus 150/5cm (606s255x/17541950) microcatheter in the correct position, he inserted the 4.5mm x 22mm enterprise (enc452212/10827625) stent vascular reconstruction device but found that it was difficult to push.The microcatheter was removed from the patient and the physician discovered a fold near the catheter tip.The microcatheter was replaced and the procedure was completed successfully without further incident.No patient complications occurred as a result of the event.The surgery was not delayed due to the event.The products were new and stored and handled according to the labeling instructions.The products were packaged securely as expected.No apparent damage was noted to the catheter packaging or shipping container.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No further information could be obtained.A non-sterile enterprise device was received inside of a pouch.Upon receipt of the complaint device, a visual inspection was conducted.The introducer tube was received separated of the unit.The distal end of the delivery wire was separated.The stent was found stuck inside of the introducer and remained on the delivery wire.There were no visual anomalies observed during the visual inspection.After the visual inspection was conducted, the introducer was inspected under microscope and residues of dried saline solution were observed inside of the introducer and on the stent.The delivery wire was inspected under microscope and it was found stretched and the edge of the separation showed evidence that it kinked before the separation.Functional testing could not be performed due to the separated condition of the received device, and because a portion of the delivery wire and stent were found stuck inside of the introducer.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The customer report of resistance/friction during advancement could not be evaluated due to the separated condition of the returned device.Additional information received indicated that the delivery wire did not separate during the procedure and when the device was packaged for return, no visual anomalies were noted.The exact circumstances surrounding the observed separation cannot be determined based on the condition of the returned device; however, it is likely that excessive force was applied to the device.The separation may have been occurred during storage, shipping, or processing after the reported event.Resistance/friction is a known potential failure associated with the use of the device.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The ifu cautions: ¿if resistanceis met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.¿ neither the device history record review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided and the evidence presented by the returned device; however, it is possible that procedural and handling factors, including device manipulation, may have contributed to the reported failure and damages noted to the returned system.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the reported complaint and the associated manufacturer report numbers are 1226348-2018-00801 & 3008264254-2018-00539.

Manufacturer Narrative

Product complaint # (b)(4).The purpose of this mdr submission is to report the results of the device history record review.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.This is one of two products involved with the reported complaint and the associated manufacturer report numbers are 1226348-2018-00801 & 3008264254-2018-00539.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EU 4.5X22MM STENT 12 MM DW TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8174440
• MDR Text Key: 131796389
• Report Number: 1226348-2018-00801
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: ENC452212
• Device Lot Number: 10827625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1